UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of susceptibility moleculde for idiopahtic pulmonary fibrosis (IPF) and chronic obstructive pulmonary disease (COPD)
Title of the study (Brief title)	Gene expression analysis of pulmonary fibrosis and emphysema
Region	Japan

Condition
Condition	idiopatic pulmonary fibrosis chronic obstructive lung disease
Classification by specialty	Medicine in general Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the molecules relating to the development of pulmonary fibrosis and emphysema by accomplishing comprehensive gene expression analysis of fibrotic and emphysematous lung tissue.
Basic objectives2	Others
Basic objectives -Others	Lung tissue without lung cancer obtained by surgical resection of lung cancer will be used. Lung tissue from patients with pulmonary fibrosis, emphysema and without these changes will be afforded to comprehensive gene expression analysis. Difference in gene expression will be analyzed to find out important molecules for pulmonary fibrosis and emphysema.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Difference in gene expression between the lung tissue from the patient with pulmonary fibrosis, emphysema and without these.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	In the case who recieved surgical resection of lung cancer, who have pumonary fibrosis or emphysema or normal lung
Key exclusion criteria	The cases with lung disases other than pumonary fibrosis and emphysema
Target sample size	100

Research contact person
Name of lead principal investigator	Mitsuru Munakata
Organization	Fukusima Medical University
Division name	Department of Pulmonary Medicine
Address	Hikarigaoka-1, Fukusima City
TEL	024-547-1360
Email	munakata@fmu.ac.jp

Public contact
Name of contact person	Mitsuru Munakata
Organization	Fukusima Medical University
Division name	Department of Pulmonary Medicine
Address	Hikarigaoka-1, Fukusima City
TEL	024-547-1360
Homepage URL
Email	munakata@fmu.ac.jp

Sponsor
Institute	Fukusima Medical University, School of Medicine
Institute
Department

Funding Source
Organization	Fukushima Medical University Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2011 Year 11 Month 15 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2011 Year 10 Month 01 Day
Anticipated trial start date	2011 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry	2014 Year 01 Month 31 Day
Date trial data considered complete	2014 Year 03 Month 31 Day
Date analysis concluded	2015 Year 05 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Retrospective, case-control study to eluciddate characteristically expressed molelules for pulmonary fibrosis and emphysema

Management information
Registered date	2011 Year 11 Month 08 Day
Last modified on	2017 Year 11 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007911